The Recall Desk
HighFDA (Devices)·Z-1563-2024·Announced 2024-04-24

Philips Ingenia 1.5T MRI systems recalled for patient support table installation defect

Philips is recalling 2,242 Ingenia 1.5T Magnetic Resonance Systems due to potential incorrect installation of the patient support table floor plate.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall for a potential installation defect in the patient support table of a medical imaging system. The source text does not report any illnesses or injuries, and the hazard is potential rather than confirmed. However, it represents a risk-of-harm situation, which qualifies as High severity.

Plain-English summary

Philips North America LLC is recalling Ingenia 1.5T Magnetic Resonance Systems (MRI systems) used in medical facilities. The recall affects approximately 2,242 systems that were distributed worldwide.

The patient support table floor plate may be incorrectly installed in some systems. Philips is conducting this recall to address the potential installation defect.

The affected systems were distributed globally, including throughout the United States and internationally to numerous countries.

Healthcare facilities should contact Philips or their medical equipment provider to verify proper installation of the patient support table floor plate.

The recalled product

Product
Ingenia 1.5T, Magnetic Resonance System.
Manufacturer
Philips North America Llc
Hazard
  • installation-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No. 781396
  • 781315
  • 782115
  • 781341
  • 782101
  • UDI-DI 884838055322
  • 884838099715
  • 884838099043
  • 884838098275
  • Serial No. Serial Number
  • 70051
  • 84508
  • 84243
  • 41044
  • 84400
  • 84537
  • 41569
  • 41104
  • 41203
  • 41195

Distribution

Distributed nationwide across the United States.